Low back pain (LBP) is one of the most common and costly problems seen in General Practitioners (GP) surgeries today. Internet interventions may provide a novel and efficient way of supporting and encouraging patients to become more active in self-managing their backs, in addition to the usual care they would receive from their GP. The aim of this study is to determine if an internet intervention called ‘SupportBack’, provided both with and without guidance from a physiotherapist over the telephone, is effective in reducing the disability LBP causes.
The results of the study will be shared internationally. If SupportBack proves to be effective, we will work towards roll-out into the NHS, allowing GPs and physiotherapists to offer patients SupportBack as a regular part of primary health care.
|Cheif Investigator:||Dr Adam Geraghy (University of Southampton)|
|Trial Manager:||Stephanie Butler-Walley (Keele CTU)|
|Sponsor / Reference Number:||University of Southampton / 31333|
|Funder / Reference Number:||NIHR Health Technology Assessment / 16/111/78|
|UKCRN Study Portfolio Reference Number:||39195|
|Registration Reference Number:||ISRCTN14736486|
|Start Date:||01 Oct 2018|
|End Date:||30 Nov 2021|
806 primary care patients will be recruited for a randomised controlled trial comparing 3 groups:
1. Usual care
2. Usual care + SupportBack.
3. Usual care + SupportBack + physiotherapist telephone support.
SupportBack provides 6 weeks of tailored materials online to support gradual goal setting, help with monitoring of back-related activities and to provide personal feedback. SupportBack is designed to provide advice, reassurance and encourage physical activity. It was developed with the help of 22 patients with LBP. The telephone physiotherapist support will include 3 brief calls over the first 6 weeks of SupportBack use. The telephone support is aimed to help with concerns, provide reassurance and encourage taking up and staying with activity goals.
Patients will be followed up at 6 weeks, 3, 6 and 12 months and asked about how LBP is affecting their daily activities, about their level of pain intensity, and a range of other LBP-related questions. The health care services the patients use will be recorded. We will test whether SupportBack with or without physiotherapist telephone support is more effective in reducing disability related to LBP compared to usual primary care alone. In addition, we will also test whether SupportBack provides value for money. We will interview trial participants to explore their experience of the care they received over the trial period, their experience of LBP and their experience of SupportBack and the telephone support for those in the intervention groups. As well as GPs, psychologists, physiotherapists, rheumatologists and statisticians, the team includes members of the public with experience of LBP; they will provide input at all stages of the study.
To determine the clinical effectiveness of the SupportBack intervention on LBP-related physical disability delivered with and without telephone Physiotherapist support in addition to usual care, compared to usual care alone.
To determine cost-effectiveness of the SupportBack intervention with and without telephone Physiotherapist support, compared to usual care.
To determine the effect of the interventions on secondary outcomes including pain intensity, risk of persistent disability, fear of movement, catastrophizing, and pain self-efficacy.
To understand the results from the randomised controlled trial (RCT) by conducting a mixed methods process evaluation exploring implementation, mechanisms of action, and context